Intradiscal electrothermal therapy (IDET) for the treatment of discogenic low back pain: patient selection and indications for use.

Discogenic low back pain resulting from internal disc disruption can be severely disabling, clinically challenging, and expensive to treat. Previously, when conservative care had been exhausted, open surgical intervention such as spinal fusion or artificial disc replacement was the only treatment option for these patients. Intradiscal electrothermal therapy (IDET), a minimally-invasive technique performed in the outpatient setting, offers an intermediate intervention between conservative care and surgery. Specific selection criteria have been refined that identify patients for treatment with IDET, ensuring maximal clinical benefit and appropriate use of healthcare resources. Indications for use were developed from review of selection criteria from published clinical reports and review articles of IDET, and further refined by identifying components with the strongest positive predictive value and by direct physician feedback. Final indications for use consist of clinical and imaging criteria. There are 5 compulsory indications for use: 1) persistent axial low back pain +/- leg pain and non-responsive to > or = 6 weeks of conservative care; 2) history consistent with discogenic low back pain without marked lower extremity neurological deficit; 3) one to 3 desiccated discs with or without small, contained herniated nucleus pulposus by T2-weighted magnetic resonance imaging, with at least 50% remaining disc height; 4) concordant pain provocation by low pressure (< 50 psi above opening pressure) discography; and, 5) posterior annular disruption by post-discography computed tomography. Using these patient selection characteristics, approximately 3 of 4 IDET-treated patients should achieve a minimal clinically important improvement in pain and disability.

Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain.

BACKGROUND: The evidence-based practice guidelines for the management of chronic spinal pain with interventional techniques were developed to provide recommendations to clinicians in the United States. OBJECTIVE: To develop evidence-based clinical practice guidelines for interventional techniques in the diagnosis and treatment of chronic spinal pain, utilizing all types of evidence and to apply an evidence-based approach, with broad representation by specialists from academic and clinical practices. DESIGN: Study design consisted of formulation of essentials of guidelines and a series of potential evidence linkages representing conclusions and statements about relationships between clinical interventions and outcomes. METHODS: The elements of the guideline preparation process included literature searches, literature synthesis, systematic review, consensus evaluation, open forum presentation, and blinded peer review. Methodologic quality evaluation criteria utilized included the Agency for Healthcare Research and Quality (AHRQ) criteria, Quality Assessment of Diagnostic Accuracy Studies (QUADAS) criteria, and Cochrane review criteria. The designation of levels of evidence was from Level I (conclusive), Level II (strong), Level III (moderate), Level IV (limited), to Level V (indeterminate). RESULTS: Among the diagnostic interventions, the accuracy of facet joint nerve blocks is strong in the diagnosis of lumbar and cervical facet joint pain, whereas, it is moderate in the diagnosis of thoracic facet joint pain. The evidence is strong for lumbar discography, whereas, the evidence is limited for cervical and thoracic discography. The evidence for transforaminal epidural injections or selective nerve root blocks in the preoperative evaluation of patients with negative or inconclusive imaging studies is moderate. The evidence for diagnostic sacroiliac joint injections is moderate. The evidence for therapeutic lumbar intraarticular facet injections is moderate for short-term and long-term improvement, whereas, it is limited for cervical facet joint injections. The evidence for lumbar and cervical medial branch blocks is moderate. The evidence for medial branch neurotomy is moderate. The evidence for caudal epidural steroid injections is strong for short-term relief and moderate for long-term relief in managing chronic low back and radicular pain, and limited in managing pain of postlumbar laminectomy syndrome. The evidence for interlaminar epidural steroid injections is strong for short-term relief and limited for long-term relief in managing lumbar radiculopathy, whereas, for cervical radiculopathy the evidence is moderate. The evidence for transforaminal epidural steroid injections is strong for short-term and moderate for long-term improvement in managing lumbar nerve root pain, whereas, it is moderate for cervical nerve root pain and limited in managing pain secondary to lumbar post laminectomy syndrome and spinal stenosis. The evidence for percutaneous epidural adhesiolysis is strong. For spinal endoscopic adhesiolysis, the evidence is strong for short-term relief and moderate for long-term relief. For sacroiliac intraarticular injections, the evidence is moderate for short-term relief and limited for long-term relief. The evidence for radiofrequency neurotomy for sacroiliac joint pain is limited. The evidence for intradiscal electrothermal therapy is moderate in managing chronic discogenic low back pain, whereas for annuloplasty the evidence is limited. Among the various techniques utilized for percutaneous disc decompression, the evidence is moderate for short-term and limited for long-term relief for automated percutaneous lumbar discectomy, and percutaneous laser discectomy, whereas it is limited for nucleoplasty and for DeKompressor technology. For vertebral augmentation procedures, the evidence is moderate for both vertebroplasty and kyphoplasty. The evidence for spinal cord stimulation in failed back surgery syndrome and complex regional pain syndrome is strong for short-term relief and moderate for long-term relief. The evidence for implantable intrathecal infusion systems is strong for short-term relief and moderate for long-term relief. CONCLUSION: These guidelines include the evaluation of evidence for diagnostic and therapeutic procedures in managing chronic spinal pain and recommendations for managing spinal pain. However, these guidelines do not constitute inflexible treatment recommendations. These guidelines also do not represent a "standard of care."

Medial branch neurotomy in management of chronic spinal pain: systematic review of the evidence.

Zygapophysial or facet joints have been implicated as cause of low back, mid back, upper back and neck pain with referred pain. Cervical, thoracic and lumbar facet joints are innervated by the medial branches of the dorsal rami. Zygapophysial (facet) joints have been implicated as the source of chronic pain in 15% to 45% of the patients with chronic low back pain, 54% to 60% of the patients with chronic neck pain and 48% of the patients with thoracic pain. A systematic review of the evidence of effectiveness of radiofrequency denervation in the management of chronic spinal pain was undertaken. This review included randomized clinical trials, as well as non-randomized or observational studies in the analysis. Literature search included MEDLINE, EMBASE, systematic reviews, narrative reviews, cross-references to the reviews and various published trials; and peer reviewed abstracts from scientific meetings during the past two years. An algorithmic approach was followed in study evaluation with a description of inclusion and exclusion criteria. A set of high-performing scales or checklists pertaining to randomized clinical trials and observational trials derived from the Agency for Healthcare Research and Quality (AHRQ) was utilized; Systems to Rate the Strength of Scientific Evidence. Qualitative analysis was conducted, using five levels of evidence for effectiveness of medial branch neurotomy. Our search strategy identified over 1,000 citations as the result of electronic and manual screening. A total of 7 randomized trials of radiofrequency neurotomy for spinal pain were identified. However, only 4 related to medial branch neurotomy. Two of the four met the inclusion criteria. Among the multiple observational studies considered for inclusion, 4 prospective evaluations were included in the systematic review. In addition, 3 retrospective evaluations were also included. Two randomized trials comprised of 27 patients receiving active treatment. The first study consisted of cervical facet joint pain and the second consisted of lumbar facet joint pain. Both studies showed positive results. Similar to randomized trials, prospective, as well as retrospective evaluations showed positive evidence, both in short-term and long-term. The results of this systematic review of 2 well-designed randomized trials, 4 prospective well-designed trials without randomization and 3 retrospective evaluations provided strong evidence that radiofrequency denervation offers short-term relief and moderate evidence of long-term pain relief of facet joint origin.

Evidence-based practice guidelines for interventional techniques in the management of chronic spinal pain.

Evidence-based practice guidelines for interventional techniques in the management of chronic spinal pain are systematically developed and professionally derived statements and recommendations that assist both physicians and patients in making decisions about appropriate health care in the diagnosis and treatment of chronic or persistent pain. The guidelines were developed utilizing an evidence-based approach to increase patient access to treatment, to improve outcomes and appropriateness of care, and to optimize cost-effectiveness. All types of relevant and published evidence and consensus were utilized. The guidelines include a discussion of their purpose, rationale, and importance, including descriptions of the patient population served, the methodology, and the pathophysiologic basis for intervention. Multiple diagnostic and therapeutic interventional techniques are included in this document. Strong evidence was shown for diagnostic facet joint blocks for the diagnosis of facet joint pain, and lumbar provocative discography for discogenic pain. Moderate evidence was shown for sacroiliac joint blocks in the diagnosis of sacroiliac joint pain, and for transforaminal epidural injections in the preoperative evaluation of patients with negative or inconclusive imaging studies, but with clinical findings of nerve root irritation. Moderate to strong evidence was shown for multiple therapeutic interventional techniques including medial branch blocks and medial branch neurotomy; caudal epidural steroid injections and transforaminal epidural steroid injections; lumbar percutaneous adhesiolysis; and implantable therapies. These guidelines do not constitute inflexible treatment recommendations. It is expected that a provider will establish a plan of care on a case-by-case basis, taking into account an individual patient's medical condition, personal needs, and preferences, and the physician's experience. Based on an individual patient's needs, treatment different from that outlined here could be warranted. These guidelines do not represent "standard of care."

American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part I--evidence assessment.

BACKGROUND: Opioid abuse has continued to increase at an alarming rate since the 1990 s. As documented by different medical specialties, medical boards, advocacy groups, and the Drug Enforcement Administration, available evidence suggests a wide variance in chronic opioid therapy of 90 days or longer in chronic non-cancer pain. Part 1 describes evidence assessment. OBJECTIVES: The objectives of opioid guidelines as issued by the American Society of Interventional Pain Physicians (ASIPP) are to provide guidance for the use of opioids for the treatment of chronic non-cancer pain, to produce consistency in the application of an opioid philosophy among the many diverse groups involved, to improve the treatment of chronic non-cancer pain, and to reduce the incidence of abuse and drug diversion. The focus of these guidelines is to curtail the abuse of opioids without jeopardizing non-cancer pain management with opioids. RESULTS: 1) There is good evidence that non-medical use of opioids is extensive; one-third of chronic pain patients may not use prescribed opioids as prescribed or may abuse them, and illicit drug use is significantly higher in these patients. 2) There is good evidence that opioid prescriptions are increasing rapidly, as the majority of prescriptions are from non-pain physicians, many patients are on long-acting opioids, and many patients are provided with combinations of long-acting and short-acting opioids. 3) There is good evidence that the increased supply of opioids, use of high dose opioids, doctor shoppers, and patients with multiple comorbid factors contribute to the majority of the fatalities. 4) There is fair evidence that long-acting opioids and a combination of long-acting and short-acting opioids contribute to increasing fatalities and that even low-doses of 40 mg or 50 mg of daily morphine equivalent doses may be responsible for emergency room admissions with overdoses and deaths. 5) There is good evidence that approximately 60% of fatalities originate from opioids prescribed within the guidelines, with approximately 40% of fatalities occurring in 10% of drug abusers. 6) The short-term effectiveness of opioids is fair, whereas the long-term effectiveness of opioids is limited due to a lack of long-term (> 3 months) high quality studies, with fair evidence with no significant difference between long-acting and short-acting opioids. 7) Among the individual drugs, most opioids have fair evidence for short-term and limited evidence for long-term due to a lack of quality studies. 8) The evidence for the effectiveness and safety of chronic opioid therapy in the elderly for chronic non-cancer pain is fair for short-term and limited for long-term due to lack of high quality studies; limited in children and adolescents and patients with comorbid psychological disorders due to lack of quality studies; and the evidence is poor in pregnant women. 9) There is limited evidence for reliability and accuracy of screening tests for opioid abuse due to lack of high quality studies. 10) There is fair evidence to support the identification of patients who are non-compliant or abusing prescription drugs or illicit drugs through urine drug testing and prescription drug monitoring programs, both of which can reduce prescription drug abuse or doctor shopping. DISCLAIMER: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."

American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2--guidance.

RESULTS: Part 2 of the guidelines on responsible opioid prescribing provides the following recommendations for initiating and maintaining chronic opioid therapy of 90 days or longer. 1. A) Comprehensive assessment and documentation is recommended before initiating opioid therapy, including documentation of comprehensive history, general medical condition, psychosocial history, psychiatric status, and substance use history. ( EVIDENCE: good) B) Despite limited evidence for reliability and accuracy, screening for opioid use is recommended, as it will identify opioid abusers and reduce opioid abuse. ( EVIDENCE: limited) C) Prescription monitoring programs must be implemented, as they provide data on patterns of prescription usage, reduce prescription drug abuse or doctor shopping. ( EVIDENCE: good to fair) D) Urine drug testing (UDT) must be implemented from initiation along with subsequent adherence monitoring to decrease prescription drug abuse or illicit drug use when patients are in chronic pain management therapy. ( EVIDENCE: good) 2. A) Establish appropriate physical diagnosis and psychological diagnosis if available prior to initiating opioid therapy. ( EVIDENCE: good) B) Caution must be exercised in ordering various imaging and other evaluations, interpretation and communication with the patient, to avoid increased fear, activity restriction, requests for increased opioids, and maladaptive behaviors. ( EVIDENCE: good) C) Stratify patients into one of the 3 risk categories - low, medium, or high risk. D) A pain management consultation, may assist non-pain physicians, if high-dose opioid therapy is utilized. ( EVIDENCE: fair) 3. Essential to establish medical necessity prior to initiation or maintenance of opioid therapy. ( EVIDENCE: good) 4. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. ( EVIDENCE: good) 5. A) Long-acting opioids in high doses are recommended only in specific circumstances with severe intractable pain that is not amenable to short-acting or moderate doses of long-acting opioids, as there is no significant difference between long-acting and short-acting opioids for their effectiveness or adverse effects. ( EVIDENCE: fair) B) The relative and absolute contraindications to opioid use in chronic non-cancer pain must be evaluated including respiratory instability, acute psychiatric instability, uncontrolled suicide risk, active or history of alcohol or substance abuse, confirmed allergy to opioid agents, coadministration of drugs capable of inducing life-limiting drug interaction, concomitant use of benzodiazepines, active diversion of controlled substances, and concomitant use of heavy doses of central nervous system depressants. ( EVIDENCE: fair to limited) 6. A robust agreement which is followed by all parties is essential in initiating and maintaining opioid therapy as such agreements reduce overuse, misuse, abuse, and diversion. ( EVIDENCE: fair) 7. A) Once medical necessity is established, opioid therapy may be initiated with low doses and short-acting drugs with appropriate monitoring to provide effective relief and avoid side effects. ( EVIDENCE: fair for short-term effectiveness, limited for long-term effectiveness) B) Up to 40 mg of morphine equivalent is considered as low dose, 41 to 90 mg of morphine equivalent as a moderate dose, and greater than 91 mg of morphine equivalence as high dose. ( EVIDENCE: fair) C) In reference to long-acting opioids, titration must be carried out with caution and overdose and misuse must be avoided. ( EVIDENCE: good) 8. A) Methadone is recommended for use in late stages after failure of other opioid therapy and only by clinicians with specific training in the risks and uses. ( EVIDENCE: limited) B) Monitoring recommendation for methadone prescription is that an electrocardiogram should be obtained prior to initiation, at 30 days and yearly thereafter. ( EVIDENCE: fair) 9. In order to reduce prescription drug abuse and doctor shopping, adherence monitoring by UDT and PMDPs provide evidence that is essential to the identification of those patients who are non-compliant or abusing prescription drugs or illicit drugs. ( EVIDENCE: fair) 10. Constipation must be closely monitored and a bowel regimen be initiated as soon as deemed necessary. ( EVIDENCE: good) 11. Chronic opioid therapy may be continued, with continuous adherence monitoring, in well-selected populations, in conjunction with or after failure of other modalities of treatments with improvement in physical and functional status and minimal adverse effects. ( EVIDENCE: fair). DISCLAIMER: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."

Improving the safety of transforaminal epidural steroid injections in the treatment of cervical radiculopathy.

BACKGROUND: Unplanned vascular trespass occurs in 20% of cervical transforaminal epidural steroid injections (CTFESI) and rarely results in devastating neurologic complications. The Trucath Spinal Injection System is a novel integrated catheter and needle device that is specifically designed to minimize vascular trespass risk. OBJECTIVE: To compare the vascular trespass incidence with the Trucath Spinal Injection System versus standard spinal needles during CTFESI treatment in patients with cervical radiculopathy. STUDY DESIGN: Prospective, multicenter, nonrandomized safety trial. SETTING: Six tertiary spinal pain management centers in the United States. METHODS: We treated 290 patients (411 levels) with recalcitrant cervical radiculopathy using CTFESI; 129 patients (180 levels) were treated with the Trucath Spinal Injection System (Test group) and 161 patients (231 levels) were treated with standard spinal needles (Control group). All injections were administered via a transforaminal approach. Each site attained IRB approval for this study before any research was performed. The primary study endpoint was vascular trespass per treated level. Secondary endpoints included nerve pain or paresthesia, injection accuracy, device performance measures, and procedural adverse events. RESULTS: Vascular trespass occurred more often (odds ratio (OR): 3.1, 95% Confidence Interval (CI): 1.8-5.4, P < 0.001) in Controls (26.8%, 62/231 levels) versus Test patients (10.6%, 19/180 levels). Radicular pain or paresthesia from device positioning was more frequent (OR: 21.1, 95% CI: 6.9-64.5, P < 0.001) in Controls (26.4%, 61/231) versus Test participants (1.7%, 3/179). Inadequate epiradicular flow was observed in 3.0% (7/231) of Controls and 5.6% (10/179) of Test participants (OR: 0.5, 95% CI: 0.2-1.4, P = 0.22). Based on subjective physician judgment (scale: 1-10), there were no differences between the Test and Control groups, respectively, for ease of use (mean 8.9 vs. 9.0), visualization under fluoroscopy (mean 9.2 vs. 9.0), and overall performance (mean 9.0 vs. 8.6). No additional adverse effects were reported in either treatment group in this clinical study. LIMITATIONS: The study did not randomly allocate the type of injection procedure to participants and no clinical outcomes beyond the initial treatment were collected. CONCLUSIONS: The Trucath Spinal Injection System demonstrated a statistically significant reduction in the rate of intravenous and intra-arterial trespass, procedural pain, and paresthesia, and has similar accuracy and performance versus standard spinal needles for CTFESI treatment of cervical radiculopathy.